FDA device listing
Stockinette; Compression Stockings; Anti-Embolism Stockings
FDA device listing 1767862841 · BOEN HEALTHCARE CO., LTD.
Key facts
| Proprietary names | Stockinette; Compression Stockings; Anti-Embolism Stockings |
|---|---|
| Owner/operator | BOEN HEALTHCARE CO., LTD. |
| Owner/operator number | 10095691 |
| Product codes | DWL |
| Device names | DWL - Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5780 |
| Review panels | General Hospital |
| Registered establishments | BOEN HEALTHCARE CO., LTD. |
| Establishment registrations | 3045058049 |
| FEI numbers | 3045058049 |
| Establishment operations | Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database